Dual chamber electronic nicotine delivery system with puff duration control and timed lockout and just-in-time adaptive intervention to treat nicotine dependence in cigarette smokers

ABSTRACT

A portable device body includes a puff opening from an inner passage. A vapor source deliver into an airflow through the inner passage a vaporized content according to a program. The program includes a first phase and a second phase. Delivery according to the first phase sets and changes, according to a first phase dosage change trajectory, a nicotine dosage from a starting nicotine dosage to an ending nicotine dosage. Delivery according to the second phase sets and changes a nicotine-to-placebo ratio according to a second phase dosage change trajectory, from a starting nicotine-to-placebo ratio to an effective zero nicotine-to-placebo ratio. The first phase dosage change trajectory is configured as statistically likely to result in user shift of nicotine intake, from smoking to electronic nicotine delivery. The second phase change trajectory is configured as statistically likely to result in user elimination of nicotine intake

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit of U.S. provisional patent application 63/228,776, filed Aug. 3, 2021.

BACKGROUND Technical Field

Embodiments pertain to treatment and assistance in cessation of smoking and elimination of nicotine intake.

Description of Related Art

According to available data, tobacco cigarette smoking kills approximately 8 million individuals per year, and that number omits the individuals' preceding debilitation and suffering, as well as impact on families, and therefore significantly understates the total cost.

Studies indicate a significant portion of tobacco smokers know the deadly effects of their smoking behavior. However, the annual death numbers are stark evidence that even for smokers who wish to quit, such knowledge of the accumulating damage and associated risks of continued smoking is not enough. A major reason for continued smoking despite knowledge of health risks is the fact that nearly all of such smokers, and particularly long term smokers, are dependent on nicotine, a psychoactive drug naturally occurring in tobacco. Nicotine dependence makes quitting difficult because of aversive symptoms that occur upon abrupt cessation of nicotine intake (e.g., during a quit attempt)—these symptoms are alleviated rapidly upon resumption of nicotine intake (e.g., relapse to smoking), leading to multiple failed quit attempts. Also, nicotine dependence may cause individuals to “rationalize away” the fact that each cigarette puff delivers, with the perceived relief by its nicotine dose, more than 4000 toxicants that are linked to cancer, cardiovascular and lung disease, and various other major health conditions.

Medications, such as nicotine replacement therapy (NRT), that may assist smokers to quit are known, but acceptance is low, and studies indicate their efficacy is limited. Another cessation technique, supported by anecdotal evidence and some clinical trials, involves the use of “electronic nicotine delivery systems” also referred to as “ENDS,” which are available from a number of commercial retail providers and vendors. ENDS are marketed as a “smoking alternative,” i.e., an alternative route to deliver nicotine to the user. However, even if the marketed purpose were met, current ENDS products and services have inherent shortcomings, that include: failure to structure their use optimally as a smoking cessation product and that ENDS products and services are not structured for eliminating, for the products' users, dependence on and corresponding habitual intake of nicotine once tobacco cigarette smoking has ceased.

SUMMARY

Embodiments provide, among other features, technical solutions to the above-identified current ENDS product deficiencies as means for assisting smokers to quit smoking and eliminate dependence on and use of nicotine. Technical solutions include a novel multiple chamber two-phase dosage control (TPDC) based electronic nicotine delivery that aids smokers in cessation of smoking and subsequent elimination of nicotine intake.

Systems according to a general embodiment include a portable device comprising, e.g., within a case or housing, an inner passage extending to a puff opening, arranged such that puffs applied to the puff opening pull an airflow through the inner passage, toward and out through the puff opening. A system according to a general embodiment can include a treatment program-based vapor source configured to deliver into the airflow a vaporized content according to a first phase dosage program, followed by delivery of vaporized content that changes according to a second phase dosage trajectory. In a general embodiment, the first phase dosage comprises a starting nicotine dosage to an ending nicotine dosage, and can span a number of puff sessions

In a general embodiment, the second phase program comprises setting and controlling the vaporized content as a nicotine-to-placebo ratio content, then changing the ratio according to a second phase dosage trajectory, from a starting, non-zero nicotine-to-placebo ratio to an effective zero nicotine-to-placebo ratio.

In one or more embodiments, the program-based vapor source can include a two-phase vapor content controller, which can be communicatively connected to and can control one or more atomizers, each having atomization emission structure, e.g., in the inner passage.

Embodiments can include one or more reservoir content transfer elements, selectively configurable by the two-phase vapor content controller, to transfer content carrier liquid, from the particular reservoirs needed to provide delivery from the puff opening of vapor content in accordance with the first phase program, and then the second phase program.

In one or more embodiments, the two-phase vapor content controller, or an external treatment processing resource, or both, can monitor indicia of a subject's progress, e.g., first phase progress toward cessation of smoking, or second phase progress toward elimination of nicotine intake, or both. Such embodiments can include, in combination with the monitoring, resources for responding to detected deviations from a target progress state. Examples can include, but are not limited to, automatic adjustment of the first phase program and/or the second phase program, or transmitting one or more types of “request to intervene” notifications, e.g., to predetermined healthcare providers or individuals.

In an embodiment, various parameters can be individualized, which can provide smokers a multiple chamber TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake assistance that can be tailored individually to deliver nicotine effectively and acceptably at every use, and concurrently changing the dosage to obtain the desired treatment results.

According to various embodiments, an example system for multiple chamber two-phase dosage control (TPDC) based electronic nicotine delivery assistance in cessation of smoking and nicotine intake, can comprise a portable device body, which can include a structure forming a puff opening fluidically connected to an inner passage, in an arrangement wherein user puffs applied to the puff opening pull an airflow through the inner passage, toward and out from the puff opening. The example can include a programmable vapor source, which can be configured to deliver into the airflow a vaporized content according to a program, the program including a first phase program and a second phase program. In the example, the first phase program can comprise setting and controlling the vaporized content according to a configuration delivering out from the puff opening a nicotine dosage according to a first phase content, including a starting nicotine dosage and an ending nicotine dosage, and the second phase program can comprise setting and controlling the vaporized content as a nicotine-to-placebo ratio content and changing the ratio, according to a second phase content change trajectory, from a starting, non-zero nicotine-to-placebo ratio to an effective zero nicotine-to-placebo ratio.

According to various embodiments, an example method for TPDC based electronic nicotine delivery assistance in cessation of smoking and nicotine intake can be provided, and can comprise, responsive to a first succession of instances of a subject's puff induced airflow through a passage toward a puff opening, delivering from the puff opening corresponding instances of a vaporized nicotine, at dosages in accordance with a first phase program, wherein the delivering includes receiving information indicative of puff characteristics of the subject that relate to actual received nicotine dosage by the subject relative to vaporized nicotine delivery operation by the system and, based on the information, performing adjustments of the delivery to conform the actual received dosage to the first phase program. The example can include, responsive to second first succession of instances of the subject's puff induced airflow, delivering from the puff opening corresponding instances of a vaporized nicotine-to-placebo ratio content and changing the ratio, according to a second phase content change trajectory, from a starting, non-zero nicotine-to-placebo ratio to an effective zero nicotine-to-placebo ratio.

Other features and advantages of the present disclosure will be set forth in the description of disclosure that follows, and in part will be apparent from the description or may be learned by practice of the disclosure. The disclosure will be realized and attained by the compositions and methods particularly pointed out in the written description and claims hereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a cross-section view of structure of an example multiple chamber two-phase dosage control (TPDC) based electronic nicotine delivery system for assistive treatment in cessation of smoking and nicotine intake according to various embodiments.

FIG. 2 shows an enlarged area of the FIG. 1 cross section, showing example structure and arrangement of reservoir functions, atomizer functions, and reservoir-to-atomizer transfer, according to various embodiments.

FIG. 3 shows a functional block schematic of an example cloud integrated TPDC based system for cessation of smoking and nicotine intake according to various embodiments.

DETAILED DESCRIPTION

Described here is a multiple chamber two-phase dosage control (TPDC) based electronic nicotine delivery system, and system-enabled treatment method, assisting smokers in cessation of smoking and subsequent elimination of nicotine use. The TPDC based electronic nicotine delivery system addresses and provides technical solution for limitations of existing ENDS products.

An example multiple chamber TPDC based electronic nicotine delivery system according to various embodiments can include a portable case or housing having a puff opening, the case enclosing an inner passage that extends to the puff opening, in an arrangement such that user puffs applied to the puff opening induce an airflow, e.g., from an air inlet, into and through the inner passage, and out from the puff opening. Supported by the case is a program-based vapor source, configured to deliver into the airflow a vaporized content according to a first phase program and then deliver a vaporized content according to a second phase program. Delivery according to first phase program includes among other features, automatic compensation, including compensating actions not detectable by the user, e.g., dynamic, per puff adjustment of vapor content, and including “low-key” intervention, e.g., reasonable tone/level audio notice, all configured to maintain the nicotine dosage received by the user in accordance with the second phase program. The maintaining users' received nicotine dosage in accordance with the second phase program is substantial because the program dosage, even if less than the user may have preferred while a smoker, significantly lessens the anxiety and other unpleasant effects of sudden, total nicotine cessation. This lessening of uncomfortable effects and modes of not-unsettling intervention when applied, in combination, may lead users to a quicker, and more successful, e.g., lower return-to-smoking rate, than attained through use of ENDS devices.

Multiple chamber TPDC based electronic nicotine delivery systems according to various embodiments, upon the user attaining the short term, but significant goal of cessation of smoking, can switch to second phase program. The goal of the second phase program, i.e., the long term goal of practices of multiple chamber TPDC based electronic nicotine delivery systems according to various embodiments, is elimination of intake of nicotine.

Delivery of vapor content according to the second phase program feature of systems and methods of multiple chamber TPDC based electronic nicotine delivery according to various embodiments, which includes delivering a characteristic, e.g., trajectory-type decreasing dosage of nicotine, that can comprise a changing of the ratio, according to a second phase trajectory, which can span a succession of user puff actions and, viewed from a larger perspective, a succession of user puff sessions.

According to various embodiments, the second phase trajectory can be configured as statistically likely to result in an elimination of nicotine intake.

In an implementation, the system can include, in the portable case: a reservoir for a nicotine carrying liquid and, associated with that reservoir, a nicotine delivery atomizer, and a reservoir for a no-nicotine carrying liquid and associated no-nicotine atomizer. In fact, if an entire smoking cessation program based on the device is followed, both reservoirs are typically employed. For example, at the start of the smoking cessation program, e.g. a “first phase” or “Phase I”, a user generally inhales vapor from only the nicotine reservoir and engages in the number of sessions that accords with his or her habitual nicotine intake when e.g. smoking cigarettes. Goals of the first phase include decreasing the users dependence on cigarettes per se and encouraging and guiding the user toward employing only the multiple chamber TPDC based electronic nicotine delivery to obtain nicotine. Information obtained by one or more embodiments in the first phase can include information that establishes a baseline of nicotine intake at which the user is initially comfortable.

Certain of the parameters used in first phase vapor delivery mode operation of a multiple chamber TPDC based electronic nicotine delivery parameters can be preset or initialized and in limited instances and contexts, controlled by the user. Examples of initialization of parameters, include, but are not limited to, any among and any combination or sub-combination of the amount of nicotine per puff, and puff duration, the puff frequency. The user-initialized parameters can also include the number of puffs per smoking session, the number of puffs and/or sessions in a given time period (hour, day, week, etc.), the puff “strength” (which influences the amount of nicotine delivered with each puff and thus ultimately, e.g., at each session, or per hour, or per day, etc.), and the like. Such initialization can avoid a training or adjustment period, such measurements and analyses resources of the multiple chamber TPDC based electronic nicotine delivery system starting with default, e.g., generic settings for these parameters, followed by measurement-based adjustment. In addition, smoking triggers may be identified, e.g. when the subject smokes or is likely to smoke, such as upon waking, before sleeping, before or after a meal, before or after sex, when engaged in a particular activity e.g. studying, writing, drawing, etc.

According to various embodiments, upon all nicotine self-administration being via multiple chamber TPDC based electronic nicotine delivery (i.e., cigarette smoking has ceased) the TPDC based stepped phase vapor content controller can shift to a second program phase mode, configured to assist the user in eliminating intake of nicotine. According to one or more general embodiments, the second phase mode can deliver to the user a trajectory type changing dosage of nicotine, which can start at the nicotine dosage delivered at the end of the first program phase mode. The TPDC based stepped phase vapor content controller can be configured to use, as dosage increment intervals, time intervals, e.g., numeric value PD days or weeks. The TPDC based stepped phase vapor content controller, according to various embodiments, can be configured to manage dosage increment intervals can be session intervals, e.g., a numeric value SD puff sessions. In one or embodiments, the dosage increment intervals can be a combination determined based on a combination or time and puff sessions.

According to one or more embodiments, the TPDC based stepped phase vapor content controller can be configured to include, in the second phase mode, receiving of adjustment commands, for example from a clinician. Implementation of such a feature can be, for example, by processor executable instructions stored in a tangible storage medium communicatively connected to a processor or processor.

In one or embodiments, the TPDC based stepped phase vapor content controller can be configured to use a linear reduction trajectory, e.g., lowering the user's per-day nicotine reception limit by a fixed increment every fixed number of days, weeks, or puff sessions. An example alternative can be a linear percent, or a combination of linear percent and a linear fixed reduction increment. According to various embodiments, the TPDC based stepped phase vapor content controller can be configured to use a non-linear dosage reduction trajectory, or a combination of linear and non-linear.

Regarding processes for the TPDC based stepped phase vapor content controller to control the vapor delivery components, e.g., control transfer of nicotine liquid from the nicotine reservoir to the nicotine atomizer, and transfer of no nicotine from the no nicotine reservoir to the no nicotine atomizer, in various embodiments the controller can be configured to perform a random selecting between the nicotine carrying reservoir and associated atomizer and the no nicotine, e.g., placebo carrying (nicotine-free) reservoir and its associated atomizer, and by progressively moving the statistics of the random section to steadily increase the frequency of selecting the placebo. The increasing frequency can be scaled to span, for example, across an overall time interval, such as weeks. Accordingly, the TPDC based stepped phase vapor content controller establishes the purpose of the placebo liquid chamber to be a slow weaning of the user away from nicotine by introducing random puffs that deliver an aerosol that contains no psychoactive drug.

According to various embodiments features can further include measuring of puff timing and duration and corresponding adjusting of vapor content to compensate for a user's specific puff characteristics that may result in differences between the program trajectory dosage and dosage the user receives. Features can also include user-controlled or otherwise variable, e.g., by a clinician, power setting designed to facilitate smoking cessation. This feature can utilize the relation between electrical power used to heat the liquid is related directly to aerosol production, and assuming all other things being equal, more aerosol means greater nicotine delivery.

In various embodiments features can include timed use periods with a time out period that can be adjusted to facilitate smoking and/or nicotine cessation. As an example, configurations of the first phase can include a constant or substantially constant nicotine dosage, e.g., over an entire puff session or over multiple puff sessions. In such configurations, maintaining the user's received nicotine dosage, e.g., as units per hour, or units per day, can include setting a maximum time duration for a user's puff session. The time duration session, or a span of f multiple puff sessions. Features can also include a panic button that allows the user to override the time out period and that also informs a clinician of its use.

According to various embodiments, multiple chamber TPDC based electronic nicotine delivery systems can include a Just-in-Time Adaptive Intervention, and implementation can include user input from the Bluetooth-enabled multiple chamber TPDC based electronic nicotine delivery device to individualize the smoking cessation and nicotine cessation intervention.

As will be understood upon reading this disclosure in its entirety that multiple chamber TPDC based electronic nicotine delivery systems according to general embodiment provide user-specific configuration of the stepped phase process. User tailorable parameters include, but are not limited to, liquid nicotine concentration, electrical power used to heat the liquid, and enablement of receiving immediate reward, e.g., vapor configured to be visible when exhaled. Another useable electable reward parameter can be a ratio of freebase to protonated nicotine, as the ratio can influence sensory effects, with more freebase nicotine producing greater throat stimulation that smokers can find rewarding (i.e., “throat hit”). In multiple chamber TPDC based electronic nicotine delivery systems and devices according to various embodiments each of these factors, e.g., nicotine concentration, electrical power, visible exhale vapor, and freebase-to-protonated ratio, can be controlled to provide the user with an individually-tailored experience, but within dosage levels and dosage change trajectories configured to obtain statistical likelihood of program success i.e., cessation of smoking and elimination of nicotine intake.

For user-individual setting, and for other uses, multiple chamber TPDC based electronic nicotine delivery system according to various embodiments can also include hardware that recognizes and records which of the liquid containing reservoirs is being used, records power setting, and both measures (and can control) user puff duration. These measurements indicate actual nicotine dosage levels the user is obtaining from the multiple chamber TPDC based electronic nicotine delivery systems and system features can include utilization of this information for generating, and updating user-specific programs configured to obtain smoking cessation and, ultimately, total nicotine cessation.

Features of multiple chamber TPDC based electronic nicotine delivery systems according to various embodiments further include automatic puff-by-puff tuning of nicotine emissions, to further monitor and maintain delivered dosages according to program trajectory, and further to program objectives for smoking cessation and nicotine elimination.

Multiple chamber TPDC based electronic nicotine delivery systems and devices according to one or more embodiments may include a user-activatable “panic button” feature, e.g., a physical button and corresponding “request intervention” software triggered by the button, for the user to override the time out period. The request intervention software may be configured to respond to the triggering by communicating, e.g., by text message, intervention request notices, to a pre-designated health professional, or intervention service provider. The intervention request notices may be sent, for example, to a pre-designated health provider.

According to one or more embodiments, multiple chamber TPDC based electronic nicotine delivery systems and devices may be paired with, and may feature interoperability with a Just-In-Time-Adaptive-Intervention (JITAI). Implementations of the combination, according to one or more embodiments can provide, among other features comprises an innovative, multiple chamber TPDC based electronic nicotine delivery+JITAI smoking/nicotine cessation platform. Mobile health technology enables remote and real-time collection/transfer of objective data via internet-connected devices/wearables. This technology facilitates personalized treatment recommendations that are temporally contiguous to when the behavior occurred, accelerating health promoting behavior change (e.g., smoking cessation). JITAIs use pre-established algorithms that cost-effectively customize intervention delivery, in real-time based on individual behavior, enhance engagement, and promote adherence. Additional behavioral goals can be clearly defined, self-efficacy can be promoted, and behavior can be regulated with objective feedback. For example, smokers often indicate that the first cigarette of the day is the hardest to quit. The system disclosed herein targets this first cigarette, by monitoring smoking and use of the multiple chamber TPDC based electronic nicotine delivery system. Successes (exclusive TPDC use within 30 minutes of waking) are reinforced with messaging immediately; lapses are followed-up immediately to identify barriers and enhance subsequent success. The cornerstone of the present approach is an ENDS that is customized for each smoker using an adaptive algorithm that enables the smoker to set targets and informs them when targets are met, while also highlighting contexts where smoking is most likely to occur.

“Nicotine” as used herein refers to the chemical L-nicotine

having the formula C₁₀H₁₄N₂. One or both of the two N atoms can be protonated. The nitrogen atom in the pyrrolidine moiety has basic properties with a pka of 8.01. The second nitrogen atom, located in the aromatic pyridine moiety, has a pka of 3.10 and can be protonated under acidic conditions.

As used herein a “nicotine-containing liquid” refers to a vaporizable, physiologically compatible liquid carrier or solvent which is capable of solubilizing nicotine in both protonated and freebase forms.

The overall external appearance of the multiple chamber TPDC based electronic nicotine delivery device provided herein can be of any of many possible forms. For example, the device may resemble a regular cigarette, cigar, pipes, a pen, a USB stick, a cell phone, a disc, etc. or another everyday item. Alternatively, the device may have an entirely different outward appearance, rectangular, box-like, circular, or a combination of these, including whimsical designs to resemble e.g. toys, cartoon characters, etc. Any suitable materials can be utilized to make the devices, e.g. metals, polymers, plastics, etc. and the devices may be of any color, e.g. a primary color, metallic sheen, etc. or mixtures of these.

First Example

FIG. 1 shows a cross-section view of structure of an example system 100 for multiple chamber TPDC based electronic nicotine delivery based assistance in cessation of smoking and nicotine intake, hereinafter “TPDC-based system 100,” for assisting smokers in cessation of smoking and elimination of nicotine intake according to various embodiments.

The example TPDC-based system 100 can comprise a case 102, configured to provide a graspable surface and form and to cover of individual components, which are described in more detail in subsequent paragraphs. Implementations of the case 102 can include a one-component case body, or a multi-component case assembly. Configurations can include a mouthpiece 104, which can surround a puff opening 106. The mouthpiece 104 can be, for example, a contiguous portion of, an integrated part of, or a removable attachment, e.g., a threaded screw attachment to, the case 102 The mouthpiece 104 can be configured, i.e., shaped and dimensioned, to enable a user to apply a suction at the puff opening 106, e.g., when the user inhales, or takes a “drag” or “puff.” The suction can in turn pull an airflow in, e.g., through air inlet port such as the example inlet port 110, for flow through an inner passage that extends to the puff opening 106. The FIG. 1 example inner passage has a segmented arrangement, comprising a first segment 112 followed by a second segment 114. For purposes of description, the FIG. 1 inner passage will be alternatively referenced as the “inner passage 112-114.”

In various embodiments, segmented arrangements of the, such as the inner passage 112-114, can configure the segments with mutually different diameters, such the first segment 112 diameter being larger than the second segment 114,as visible in FIG. 1 . Since the FIG. 1 arrangement positions the first atomizer 118 within the first segment 112 and the second atomizer 124 within the second segment 114, and each of the two atomizers extends widthwise the full width of its respective channel segment, the first atomizer 118 has a larger diameter than the second atomizer 124. an arrangement include slower flow velocity through the first atomizer 118 than through the second atomizer 124. Secondary features of the velocity difference are described in more detail in later paragraphs.

The TPDC-based system 100 according to various embodiments, provides a program-based dynamically controlled vapor source that, as described in more detail in the following paragraphs, delivers into the inner passage 112-114 a vaporized content according to a program. In the FIG. 1 system 100 configuration, hardware providing the program-based dynamically controlled vapor source can include a two-phase dynamic vapor delivery control logic 116, hereinafter alternatively “two-phase logic 116, a first reservoir 118 and associated first atomizer 120, a second reservoir 122 and corresponding second atomizer 124. Powering the identified hardware can be a power source 126, which can comprise a battery, and various alternatives, as described in more detail later herein.

To provide additional perspective,example features and operations of the TPDC-based system 100 will be further described assuming first reservoir 118 is configured to hold a carrier liquid carrying nicotine, i.e., a nicotine containing liquid, and that the second reservoir 122 is configured to hold a carrier liquid carrying no-nicotine content, i.e., being a no-nicotine liquid. Subsequent description therefore alternatively reference the first reservoir 118 as the “nicotine reservoir 118” and the second reservoir 122 as the “no-nicotine reservoir 122. It will be understood that “no-nicotine liquid” and “liquid carrying no-nicotine content,” as used in this disclosure encompass both a liquid carrying a placebo content and a liquid carrying no content, i.e., pure carrier liquid, except where explicitly stated or made clear from the context to mean otherwise.

The two-phase dynamic vapor delivery control logic 116 can be, but is not necessarily, a distributed resource, and is therefore represented on FIG. 1 by dotted line. The two-phase logic 116 can be implemented, for example, as a locally distributed architecture comprising a device-internal hardware within the case 102, such as a microcontroller with an interface to a near range, standard protocol wireless link, e.g., Bluetooth, that communicatively connects the microcontroller to a processing resource of what may be a mobile device, such as a smartphone. The processing resource of the mobile device can be configured as a special purpose computer by a combination of the smart phone process and executable instructions stored in the smart phone memory, for performing processes in two-phase dynamic vapor delivery control as described herein, for example but not limited to, in reference to FIG. 3 .

For purposes of description, the first reservoir 118, the associated first atomizer 120, the second reservoir 122, and the associated second atomizer 124, together with details of these components further described in reference to FIG. 2 , and capacity of the power source 126 allocated for these components, will be collectively referenced as “system 100 vapor content selection and delivery apparatus.”

In overview, features of the two-phase dynamic vapor delivery control logic 116 control of the described system 100-phase vapor content selection and delivery apparatus include delivery, into the user-induced airflow through the inner passage 112-114 of a vaporized content according to a program that includes a first phase program and a second phase program. The delivery according to the first phase program comprises setting and controlling the vaporized content with a configuration that delivers into the airflow through the inner passage 112-114 a nicotine dosage, and that changes the delivered nicotine dosage according to a first phase dosage change trajectory, from a starting nicotine dosage to an ending nicotine dosage. The first phase nicotine delivery can include, for example, by activated transfer of content of the nicotine liquid reservoir 118 to the first atomizer 120.

Delivery according to the second phase program can comprise setting and controlling the vaporized content as a nicotine-to-placebo ratio content and changing the ratio, according to a second phase dosage change trajectory, from a starting, non-zero nicotine-to-placebo ratio to an effective zero nicotine-to-placebo ratio.

As seen in FIG. 1 , according to various embodiments, inner passage first segment 112 and the inner passage second segment 114 having mutually different diameters, Features of such implementation include, due to the cross-sectional flow area at the first atomizer 122 being larger than at the second atomizer 202, coupled with the total flow rate being constant over inner passage 112-114, the flow velocity at the first atomizer 122 being lower that the flow velocity at the second atomizer 202. Different air flow velocity at the respective atomizers may, together with other result-effective parameters, determine the aerosol particle size of the aerosols. In one or more embodiments, implementations of the inner passage 112-114 can include the diameter of the first segment 112 and the diameter of the second segment 114 being mutually identical.

It will be understood that the FIG. 1 example first reservoir 118 and second reservoir 122 are not intended as an implicit limitation on the population of separate reservoirs. Systems according to various embodiments an include, for example, additional reservoirs, such as, without limitation, an acid carrying reservoir.

As described above in reference to the airflow 108, the casing 102 can include one or more air inlet ports, such as the example inlet port 110, positioned for entry into the inner passage 112-114 at positions preceding the first atomizer 118 and second atomizer 124, with respect to the airflow 108 direction.

In an embodiment, atomizer 122 is connected to nicotine-containing liquid reservoir 118 so as to produce nicotine-containing aerosols (vapors) from the liquid solution contained in nicotine-containing liquid reservoir 118.

In an implementation the power source 126 may be a battery, e.g., a permanent rechargeable battery (a manufacturer-supplied sealed unit), a non-rechargeable battery, or a user-replaceable battery (rechargeable or non-rechargeable). The power source 126 may use, for example, a portable chargeable carrying case, such as available from various vendors for conventional ENDS products. Battery implementation of power source 126 may use, e.g., nickel-cadmium (NiCad), nickel metal-hydride (NiMh), lithium ion (Li-ion), alkaline and lithium polymer (Li-poly), or lithium manganese (LiMn) batteries. Another example TPDC-based system according to various embodiment may incorporate FIG. 1 system 100 and may include, as a supplement to or an alternative to the power source 126, a standard protocol connection port, e.g., USB-A or USB-C, and either configure the electrically powered components of the system 100 to use the standard protocol voltage level, or include in the system 100 a voltage converter, e.g., a DC-to-DC voltage converter.

An example TPDC-based system 100 can further comprise a manually operated activator, such as the example activator button 128 for activating the first atomizer 120 and/or the second atomizer 124. Alter can use alternative aspects, TPDC-based comprises other arrangements for activating atomizer 124 and/or the FIG. 2 second atomizer 202, for example, an air flow sensor for detecting when a user has applied a mouth generated vacuum to mouthpiece 104.

Referring to FIG. 1 , the TPDC-based system 100 can comprise a “panic button” 128. The panic button 130 can connect, for example to an “interrupt” input of a processor component the two-phase dynamic vapor delivery control logic 116. In the above-described distributed arrangement of the two-phase dynamic vapor delivery control logic 116, the device internal logic may be configured to send, e.g., over the Bluetooth link to the smartphone, a “panic button pressed” signal or code, to which a “panic button alert” app or equivalent on the smartphone can respond by sending, or conditionally sending based on other factors, a panic button alert message, e.g., to pre-designated recipients.

In an implementation, the two-phase dynamic vapor delivery control logic 116 can be further configured to allow the user, by pressing the panic button 130, to override a programmed “lock-out” time, described elsewhere herein.

In another example configuration, the two-phase dynamic vapor delivery control logic 116, or another logic resource, such as another app on the smartphone, can be further configured to allow the user, by pressing the panic button 128, to optionally trigger an alert to a clinician that is supervising or monitoring the user's progress with respect to smoking cessation, e.g., by initiating a JITAI via a wireless connection, also described further elsewhere herein.

In configurations that include two atomizers, e.g., the nicotine or first atomizer 120 and the nicotine-free or second atomizer 124, the second atomizer 124 can be connected, or selectively connected to the nicotine-free liquid reservoir 122 to deliver from the puff opening 106 nicotine-free aerosols (vapors). With reference to FIG. 2 , which is an expanded view of a portion of the FIG. 1 cross-sectional side view, the first atomizer 122 is shown comprising a first transport element 202 and a first heating element 204. The first transport element 202, which can be for example a wick, capillary tube, etc., can be selectively operated to establish fluid communication with nicotine-containing liquid reservoir 118, when the first heating element 204 (being, for example, a coil, wires or ceramic heater) of the first atomizer 120 is activated. Similarly, a second transport element 206 may be in fluid communication with nicotine-free liquid reservoir 122, and a second heating element 208 when the second atomizer 124 is activated. First heating element 204 and second heating element 208 may be activated by any suitable trigger means, e.g., activated by the change in pressure or air flow that occurs when the user inhales, by mechanical activation via a switch or button, etc.

In alternative embodiments the first atomizer 122, or the second atomizer 124, or both may comprise additional and/or alternative elements. For example, either the first heating element 204 or the second heating element 208 or both may be implemented by a heating element other than a heating coil. In another example, either the first atomizer 120, or the second atomizer 124, or both, may employ ultrasonic vibration atomizer components, produce an unheated aerosol. In another example, either the first transport element or the second transport element 206, or both, may be implemented my means other than wick.

In further exemplary implementations, nicotine-free liquid reservoir 122 may be operably connected to an atomizer that is different from (is not) atomizer 124. In such embodiments, second atomizer 124 can comprise second transport element 206 being, for example a wick in fluid communication with nicotine-free liquid reservoir 122, and second heating element 208 can be, for example, a coil for heating and atomizing when the second atomizer 124 is activated. In one or more embodiments, second heating element 208 can be a coil arranged around a portion of second transport element 206, e.g. a wick. A feature of such an arrangement is that when the second heating element 208 the coil is heated, provides resistive heating by means of power source 126. In alternative embodiments the atomizers may comprise additional and/or alternative elements. In one or more embodiments, implementation of the second heating element 208 can include a plate or a tube, heated for example by resistive heating. In one or more embodiments, the second transport element 206 may be implemented as, or to include, e.g., a tube, such as a capillary tube, and/or may comprise a pump, such as an electronic pump. According to various embodiments, one or both of the first atomizer 118 and second atomizer 124 atomizers may not comprise heating elements.

In implementations according to one or more embodiments, nicotine-containing liquid reservoir 118 and/or nicotine-free liquid reservoir 122 can be removable and replaceable, e.g. as a single cartridge, for example by removing the mouthpiece 104 and sliding the containers out by that end. Alternatively, casing 102 may comprise a removable section that is hinged or configured to snap into place so that the removable section of the casing, when removed, allows access to nicotine-containing liquid reservoir 118 and/or nicotine-free liquid reservoir 122 cartridges.

In one or more embodiments the first atomizer 122 and/or second atomizer 124 may be physically connected to nicotine-containing liquid reservoir 118 and nicotine-free liquid reservoir 122, respectively, and thereby removable together with the containers as a single cartridge. In other embodiments, the containers may be removed without the atomizers e.g. as a single cartridge or as separate cartridges, e.g., one for each container.

According to one or more embodiments an TPDC-based system can be configured in general accordance with FIG. 1 , except for replacing the nicotine reservoir 118, and the first atomizer 120 with a first cartomizer, i.e., a cartridge containing a solution of nicotine with a built-in atomizer and/or replacing the no-nicotine reservoir 122, and the corresponding no nicotine or second atomizer 124 with second a cartomizer, i.e., a cartridge containing a solution of non-nicotine and containing another built-in atomizer.

As identified above, according to various embodiments, in implementations using segmented, such as the first segment 112 and second segment 114, not having the same diameter, inner passage such as the inner passage first segment 112 and the inner passage second segment 114, the first atomizer 120 and the second atomizer 124 can be longitudinally displaced, i.e., spaced apart along the direction of the airflow 108, such that the first atomizer 120 is within the inner passage first segment 112 and the second atomizer 124 is within the inner passage second segment 114. Features of such implementation include, due to the cross-sectional flow area at the first atomizer 120 being larger than at the rate at the second atomizer 124, coupled with the total flow rate being the same all along the inner passage 112-114, the flow velocity at the first atomizer 120 is lower than the flow velocity at the second atomizer 124. Different air flow velocity at the respective atomizers may, together with other atomization result-affecting parameters, determine the aerosol particle size of the aerosols. It will be understood that mutually different diameter segments is only one configuration, It is not and is not intended as a limitation on practices according to one or more embodiments. In one or more embodiments, implementations of the inner passage 112-114 can include the diameter of the first segment 112 and the diameter of the second segment 114 being mutually identical.

It will be understood that the FIG. 1 graphic block 116, referenced herein as the two-phase dynamic vapor delivery control logic 116, places no limitation on the hardware implementation of the logic. represents a processing and control resource that interfaces and controls, as described above, certain of the functional components of the TPDC-base system 100 to perform as described. According to various general embodiments a TPDC-based system 100 can include an electrical control implementation, such as the two-phase dynamic vapor delivery control logic 116,that can include a plurality co-operating different units, e.g., in one housing, or it may even be integrated into other units, e.g. a power supply. The electronic control arrangement can be electrically connected to the atomizers 120 and 124, and the activation arrangement, such as the activation button 128. An illustrative example of such electrical control arrangement is shown in FIG. 1 , where electrical connections 132 are shown connecting power source 126 to activator button 128 and to the atomizers 120 and 124, which are in turn connected to activator button 128.

In one or more general embodiments, the electronic control arrangement can provide functionality through which the user can control the effective dose delivered by the included atomizers using automatic regulation of the electrical power supplied to the atomizer by the power supply and/or regulation of the activation time. Furthermore, the electronic control arrangement may, if more than one atomizer is in use, be adapted for control, by the user, of the activation of all atomizers in a synchronized manner. For example, the amount of nicotine in vapor delivered to the user may be adjusted by the user, and may be e.g. increased or decreased, or nicotine may be eliminated, by varying the ratio of nicotine-containing liquid to nicotine-free liquid that is vaporized and delivered.

According to various general embodiments, the electronic control arrangement for the TPDC-based system, e.g., the two-phase dynamic vapor delivery control logic 116, can include an electronic control arrangement featuring means for imposing and for adjusting a delay of a predetermined period of time between the activation of the atomizers. Further, in accordance with various embodiments, the electronic control can be further configured to provide control of the dose supplied to the atomizer and/or the aerosol particle size of the aerosols produced by the atomizer.

Example TPDC-based systems according to various general embodiments can further comprise a range of additional features, such as, without limitation, an air flow sensor, temperature sensor, micro-pumps in microelectromechanical systems, pumps to facilitate the appearance of sidestream smoke to further simulate traditional smoking, Other aspects of the TPDC-based disclosed herein may comprise alternative components and component designs (e.g. mouthpieces, cartridges, etc.) or arrangements of components known in the art and described, for example, in published US patent applications 20170251726, 20170105450, 20170367407, 20220192254, 20220202087, 20220183351, the complete contents of each of which is herein incorporated by reference in its entirety.

Microprocessors, programmable logic units, integrated circuits and other electronic components may be incorporated into the TPDC-based systems. The electronic components may be used to power components and in conjunction with a liquid crystal screen to display and/or record operating state parameters, such as battery life, use frequency per day, average use cycle and safety warnings. However, the microprocessor may also have additional functions such as the ability to control integrated components (e.g., pumps and/or motors) that deliver specifically programmed product quantities or concentrations. Wireless communication protocol integration and multiple smoking software programs based on fluid type and user preference are options. Generally, in order to implement the tailored, individualized features of the TPDC-based systems, control resources can comprise at least one programmable integrated circuit, typically a microchip which functions as a primary circuit board, discussed further elsewhere herein.

Example Hardware

Features of multi-chambered TPDC-based systems according to various embodiments can include, but are not limited to, being programmable by the user and/or by a clinician. Programmability can include enabling the user to set the initial or baseline program, and to implements a smoking cessation program using initial parameter settings previously stored by the user. This can be accomplished by entering data, preferences and selections, e.g. using a personal computer, smart phone, tablet, wristwatch, an TPDC-based dedicated wearable device, etc. that is linked to the TPDC-based device and configure to options (e.g. a menu), receive user input, and transmit instructions regarding the choices made by the user to the TPDC-based device to be implemented when the ENDS is used.

In one aspect of the technology, the microchip of the device includes a wireless or wired connection (is wireless-enabled). Thus, input from the user, a clinician and/or data measurements can be sent to and retrieved from the device via a connection from, e.g., a phone or other wireless-enabled device (iPad, PC, tablet, mobile phone, wristwatch, or other wearable device, etc.) as desired.

FIG. 3 shows a schematic view of an exemplary system comprising a multiple chamber TPDC based electronic nicotine delivery system 100, with a wireless interface microchip 302, and a smart phone 304 or other wireless enables mobile processing device communicatively connected to a cloud server 306. The wireless connection through the wireless interface microchip 302 provides for actuation and/or programming of the multiple chamber TPDC based electronic nicotine delivery system 100 from the smartphone 304. In an implementation, technology, wireless-enabled device, e.g., the smartphone 304 comprises an application programming interface (API) 308 that is programmed to retrieve and process information from the TPDC-based system 100 that is specifically correlated to the user. The API 308 can be, for example, an executable software module stored in a tangible storage medium based instruction memory 310 that is connected, e.g., by a bus 312, to a processing logic 314, e.g., a processing chip such as, but not limited to, a Qualcomm™ Snapdragon™ or an Apple™ A10™, A12™, and so forth. This information can be used to develop and/or revise a smoking cessation plan for the user.

Any suitable wireless or wired connection that will allow the user to configure the settings of the TPDC-based system 100 for the individual user's needs may be used. For example, the device may be Bluetooth enabled. Alternatively, an RF communication protocol, an infrared communication protocol, a wireless USB communication protocol, a ZigBee communication protocol, a cellular communication protocol, a Wi-Fi (IEEE 802.11x) communication protocol, or an equivalent wireless communication protocol which would allow secure, wireless communication of several units (for example, per HIPPA requirements) while avoiding potential data collision and interference, could be used. In another aspect, however, the TPDC-based system 100 can be configured manually without a wired or wireless connection to a peripheral device.

A range of different configurations of APIs are contemplated, e.g., to provide remote programming, program revision and monitoring of the multiple chamber TPDC based electronic nicotine delivery system. The APIs can describe and prescribe a specification or set of rules while the library is an actual implementation of this set of rules. A single API can have multiple implementations in the form of different libraries that share the same programming interface.

In one aspect, the Bluetooth enabled communication device (e.g., the smartphone 304, tablet, etc.) can be configured with a repository (or access to a repository via a local or cloud-based server) of information related to the user including, but not limited to, the user's medical history, the user's historical use of the multiple chamber TPDC based electronic nicotine delivery system, and other useful information for developing a plan for smoking cessation.

According to one aspect of the technology, the cloud server 306 is configured to provide patient data processing services. According to one aspect, the cloud server 306 includes a data gateway manager to automatically and/or manually transfer relevant data to/from data providers. Such data gateway management may be performed based on a set of rules or policies, which may be configured by an administrator or by other authorized personnel. In one aspect, in response to updates to data retrieved from the multiple chamber TPDC based electronic nicotine delivery system 100 or data processing operations performed at the cloud, the data gateway manager is configured to transmit over a network (e.g., Internet or intranet) the updated data or data representing the difference between the updated data and the original data. Similarly, the data gateway manager may be configured to transfer any new data e.g. from the user and store them in a data store of the cloud-based system. In addition, the data gateway manager may further transfer data amongst multiple data providers e.g. the user and/or a medical professional (such as a physician, psychologist, psychiatrist, etc.) and/or a life coach, and/or a technical expert with knowledge about the operating system, and/or a scientist or analyst planning to compile data for research purposes. The gateway manager may comprise a router, a computer, software or any combination of these components.

Further information and alternatives for e.g. Bluetooth enablement are found, for example, in published US patent applications 20190298941, 20220203365 and 20220180075, the complete contents of each of which are hereby incorporated by reference in entirety.

Referring to FIG. 3 , via the cloud server 306 and interface APIs of the smartphone 304, data measurements pertaining to the user may be reviewed by a medical practitioner (professional), via secure access through the cloud server 306 for evaluation of the user's progress. For example, the amount and frequency of nicotine intake can be monitored, situations that trigger cigarette smoking can be identified, etc. Accordingly, the user and/or the medical practitioner may develop and program a specific operational protocol for each individual user based on his or her unique needs. According to various embodiments, a larger scope of medical history of the user may also be considered, in a HIPAA compliant process, via, e.g., configuration of APIs on the smartphone 304, and third party secure cloud distribution services.

In one or more embodiments, an example multiple chamber TPDC based electronic nicotine delivery system can include a just-in-time adaptive intervention (JITAI) support. Examples can include, in the JITAI support, provisions for one or more wireless connection, via the wireless connection. Features of JITAI can include enablement of intervention to provide the right type/amount of support, at the right time, by adapting to an individual's changing internal and contextual state. The availability of increasingly powerful mobile and sensing technologies underpins the use of JITAIs to support health behavior, as in such a setting an individual's state can change rapidly, unexpectedly, and in his/her natural environment. An intervention design aiming to provide just-in-time support, by adapting to the dynamics of an individual's internal state and context. JITAIs operationalize the individualization of the selection and delivery of intervention options based on ongoing assessments of the individual's internal state and context.

Configurations of JITAI can include one or more among a plurality of features, including, for example and not limited to, distal outcome, proximal outcomes, decision points, intervention options, tailoring variables, and decision rules. In practices according to various embodiments, target end states can include, for example, and without limitation, cessation of smoking, as well as intermediate states such as, for example, cessation of cigarette for intake of nicotine, or at least to decrease nicotine dependence.

Distal outcome: The ultimate goal of a program, which in the context of the present embodiments is cessation of smoking and elimination of all nicotine intake. Proximal outcomes: The short-term goals the intervention is intended to achieve. Proximal outcomes can be mediators, namely crucial elements in a pathway through which the intervention can impact the distal outcome, and/or intermediate measures of the distal outcome. In the present disclosure, an example of a proximal outcome is the switch from using cigarettes to using only the multiple chamber TPDC based electronic nicotine delivery system, a decrease in the amount of nicotine that is inhaled, etc. Decision points: Points in time at which an intervention decision must be made. This may include when the user employs the panic button. Intervention options: Array of possible treatments/actions that might be employed at any given decision point. This might include various types of support, from various sources, different modes of support delivery, various amounts of support or different media deployed for support delivery. For example, a medical practitioner may contact the user directly to discuss why the panic button was used and to provide suggestions for avoiding the use of the panic button by modifying the program and/or behavioral changes the user can implement to avoid panic button usage in the future. Tailoring variables: Information concerning the individual that is used for individualization e.g. to decide when and/or how to intervene, such as when the panic button is used, when a user appears to have stopped using the multiple chamber TPDC based electronic nicotine delivery system before completing a program, etc. Decision rules: A way to operationalize the adaptation by specifying which intervention option to offer, for whom, and when (i.e., under which experiences/contexts). The decision rules link the intervention options and tailoring variables in a systematic way.

Illustrative Uses of Multi-Chamber Tpdc Based Electronic Nicotine Delivery

Features can include delivery to the user of vaporized liquid from one or both of i) the nicotine reservoir and ii) the non-nicotine reservoir. In fact, if an entire smoking cessation program based on the device is followed, both reservoirs are typically employed. For example, at the start of the smoking cessation program, e.g. a “first phase” or “Phase I”, a user generally inhales vapor from only the nicotine reservoir and engages in the number of sessions that accords with his or her habitual nicotine intake when e.g. smoking cigarettes. The goal of this initial phase is to decrease the user's dependence on cigarettes per se and to switch the user to employing only the multiple chamber TPDC based electronic nicotine delivery system to obtain nicotine. Information obtained in this phase establishes a baseline of nicotine intake at which the user is initially comfortable. In this phase, several parameters are initiated and controlled by the user, for example, one or more of the amount of nicotine per puff, puff duration, puff frequency, number of puffs per smoking session, number of puffs and/or sessions in a given time period (hour, day, week, etc.), puff “strength” (which influences the amount of nicotine delivered with each puff and thus ultimately e.g. at each session, or per hour, or per day, etc.), and the like. In addition, smoking triggers may be identified, e.g. when the subject smokes or is likely to smoke, such as upon waking, before sleeping, before or after a meal, before or after sex, when engaged in a particular activity e.g. studying, writing, drawing, etc.

Once all nicotine self-administration is via multiple chamber TPDC based electronic nicotine delivery (i.e., cigarette smoking has ceased) the multiple chamber TPDC based electronic nicotine delivery elimination phase begins. The software may be programmed to provide, during this phase, random switching to the placebo reservoir with the placebo (nicotine-free) liquid, with increasing frequency across weeks. This can assist in slowly weaning the user away from nicotine by introducing random puffs that deliver an aerosol that contains no psychoactive drug. In another implementation, the contents of the nicotine reservoir and the non-nicotine reservoir may be mixed to gradually deliver a lower dose of nicotine per puff.

In addition, the hardware includes a timed lockout feature that allows puffs during a set interval (e.g., about 1-10 minutes, such as about 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 minutes, in particular 5 minutes) and then prohibits them (i.e., the heater is not activated even if the user e.g. puffs on the device) for a “time out” period (e.g., about 5-60 minutes, such as about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, or 60 minutes, in particular about 30 minutes). During the cigarette cessation phase, this time out period is used to avoid the user becoming accustomed to regular, constant nicotine dosing. That is, during the cigarette-cessation phase, the user can only receive nicotine from the device for, e.g., 5-minute use episodes, followed by 30 minutes of non-use (time-out or lock-out period).

However, as described above, control software generally can include a “panic button” mode that allows the user to override the time out period. Pressing the panic button triggers a software response that leads to therapeutic intervention, e.g., JITAI via, for example, a smartphone app. During the TPDC-based system elimination phase, the time out period is gradually increased (i.e., from 30 to 35 minutes, from 35 to 40 minutes, etc.) such that, near the end of this phase, the user breaks free from nicotine dependence by virtue of fewer puffs that deliver nicotine (i.e., more puffs from the placebo liquid chamber) and longer intervals between nicotine self-administration episodes (via the longer time-out period).

It is to be understood that this disclosure is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Representative illustrative methods and materials are herein described; methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosure.

All publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure. Further, the dates of publication provided may be different from the actual dates of public availability and may need to be independently confirmed.

It is noted that, as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as support for the recitation in the claims of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitations, such as “wherein [a particular feature or element] is absent”, or “except for [a particular feature or element]”, or “wherein [a particular feature or element] is not present (included, etc.) . . . ”.

As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present disclosure. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.

The disclosure is further described by the following non-limiting examples which further illustrate the invention, and are not intended, nor should they be interpreted to, limit the scope of the disclosure.

Example

A 34-year old male subject has been smoking tobacco cigarettes for 10 years. His usual daily intake is one pack of tobacco cigarettes per day. The subject agrees to utilize the smoking cessation device disclosed herein in order to quit smoking with the goal of eventually becoming free of all nicotine intake. The multiple chamber TPDC based electronic nicotine delivery disclosed herein is prescribed by his physician.

The initial settings as programmed by the subject and/or his prescribing physician deliver 1.5 mgs of nicotine to the subject 20 times per day to approximate his usual nicotine intake from cigarettes, i.e. 0.15 mgs per puff during 20, 5-minute smoking sessions, each of which comprises 10 puffs. In addition, having sampled several variations of liquids and power settings, the subject chooses the liquid nicotine concentration, device power setting, PG/VG ratio, and freebase:protonated ratio to individualize nicotine delivery (a function of liquid concentration and device power), visible exhalation (a function of PG/VG ratio) and throat hit (a function of freebase:protonated ratio). Based upon information provided by the subject, the device is programmed to allow 10 puffs in 5 minutes, with a 20-minute programmed time out period before additional puffs are allowed (i.e., the subject may puff during this interval, but the heater will not be activated, and no aerosol will be emitted). The subject is instructed on the use of the panic button, such that, if the subject feels a strong urge to smoke during a time out period, a press of the panic button voids the time out period and allows nicotine-delivering puffs to be taken from the device. Pressing the time out button also activates the Just-In-Time-Adaptive-Intervention (JITAI) feature, such that a smoking cessation counselor is notified that the panic button was pressed, and the counselor can then initiate a text/voice contact with the subject to identify the cause of the panic button's use, and the subject and counselor can discuss behavioral strategies for avoiding further panic button usage. Also, based upon information provided by the subject and/or by information collected via smartphone/wearable, the device is programmed to notify a counselor if a puff is not taken from the device within 30 minutes of waking. The goal of this notification is to maximize the likelihood that the subject uses the device (and not a tobacco cigarette) for nicotine self-administration immediately upon waking, which many smokers identify as the most important time of day for smoking. Over the course of a 6-week period, empowered by the nicotine from the device, the individualized aerosol production selection, and the JITAI feature, the subject gradually reduces his cigarette intake such that, at the end of the 6-week period, all nicotine intake comes from the device, the panic button is not used, and the device is used within 30 minutes of waking every day. The subject is able to track his nicotine delivery and panic button usage on a regular basis, due to data provided by the device to a cloud server that returns relevant information in an accessible format (e.g., a graph showing nicotine intake hour-by-hour, across days). This feedback allows the subject to maintain awareness of his nicotine self-administration and observe how increasing device usage (and decreasing cigarette smoking) controls nicotine intake.

This pattern of nicotine intake from the device (and never a cigarette) is maintained for an additional 2 weeks, demonstrating that the subject uses the device exclusively (no cigarettes smoked) and has complete control over his nicotine self-administration. Phase I of the treatment is now complete, as the subject is not smoking tobacco cigarettes and is still self-administering nicotine through exclusive use of the device.

Once Phase I (cigarette cessation) is complete, Phase II (nicotine cessation begins). Two features of the device are now activated by the physician and/or the counselor. First, the time out period (20 minutes) is gradually increased across weeks (e.g., 25 minutes in week 1, 30 minutes in week 2, etc.). This feature allows the subject to obtain longer and longer intervals between periods of nicotine self-administration. Second, using an algorithm, the device begins introducing placebo puffs (i.e., activating the non-nicotine liquid reservoir) into one or more 10-puff use episodes. These placebo puffs occur randomly, with the exception that they never occur on the first puff of a 10-puff use episode and, during the first week, they never occur on the first use episode of the day. The panic button is still available, and using it provides access to nicotine-containing puffs and also initiates contact from the counselor. Again, the subject can track his nicotine intake hour-by-hour and over days, enabling him to see the success he has achieved via the longer timeouts and the randomly introduced placebo puffs. Across weeks, depending on subject progress and use of the panic button, more and more placebo puffs are introduced randomly, according to an algorithm. Over the course of 8-12 weeks (again, depending on progress and use of the panic button) most or all of the puffs taken are obtained from the placebo reservoir, rendering the subject non-nicotine dependent. Once 100% nicotine-free puffs have been delivered for 2 weeks, the counselor contacts the physician and an appointment is scheduled. The physician/counselor and subject discuss the subject's nicotine-free status, and the subject is encouraged to reduce use of the device but not required to stop using it. Over the next four weeks the subject spontaneously quits using the device because the physiological “need” to take puffs has been eliminated. In this manner, the device has achieved the goal of total nicotine cessation by virtue of first gaining the subject's control over nicotine self-administration (Phase I) and then gradually reducing the amount of nicotine that is self-administered to 0 mg/puff (Phase II).

While the invention has been described in terms of its several exemplary embodiments, those skilled in the art will recognize that the invention can be practiced with modification within the spirit and scope of the appended claims. Accordingly, the present invention should not be limited to the embodiments as described above, but should further include all modifications and equivalents thereof within the spirit and scope of the description provided herein. 

We claim:
 1. A system for two-phase dosage control (TPDC) based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, comprising: a portable device body, comprising structure forming a puff opening fluidically connected to an inner passage, in an arrangement wherein user puffs applied to the puff opening pull an airflow through the inner passage, and out from the puff opening; and a program-based dynamically controlled vapor source, configured to deliver into the airflow a vaporized content according to a program, the program comprising a first phase program and a second phase program, wherein: delivery according to the first phase program comprises setting and controlling the vaporized content with a configuration that delivers into the airflow a nicotine dosage and that controls the delivered nicotine dosage according to a first phase dosage trajectory, from a starting nicotine dosage to an ending nicotine dosage, and delivery according to the second phase program comprises setting and controlling the vaporized content as a nicotine-to-placebo ratio content and changing the ratio, according to a second phase dosage change trajectory, from a starting, non-zero nicotine-to-placebo ratio to an effective zero nicotine-to-placebo ratio, the second phase dosage change trajectory is configured as statistically likely to result in an elimination of nicotine intake.
 2. The system of claim 1 for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the program-based dynamically controlled vapor source is further configured to: a) count first phase puffs by the subject, and to measure timing features of the first phase puffs and, based at least in part on the count of the first phase puffs or the timing features of the first phase puffs, or both, to detect occurrence of first phase puff sessions by the subject and to count the detected occurrences of first phase puff sessions by the subject, or b) count second phase puffs by the subject, and to measure timing features of the second phase puffs and, based at least in part on the count of the second phase puffs or the timing features of the second phase puffs, or both, to detect second phase puff sessions by the subject and to count the detected second phase puff sessions by the subject, or both a) and b).
 3. The system of claim 1 for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein: the second phase dosage change trajectory is configured as statistically likely to result in an elimination of nicotine intake.
 4. The system of claim 1 for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the second phase program is configured to change the nicotine-to-placebo ratio by controlling a nicotine-to-placebo statistical ratio of a random selecting, on a per-puff basis, between nicotine content and placebo content, wherein: the random selecting includes generating a random number according to a uniform probability density function, and comparing the generated number against a selection comparison threshold, and changing the ratio comprises changing the stored selection comparison threshold to an updated selection comparison threshold.
 5. The system of claim 1 for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the first phase program further comprises a programmable lock-out process, which comprises: enabling, for an enablement time interval, the programmable vapor source to deliver into the airflow the vaporized content, and disabling, for a lock-out time interval, the programmable vapor source from delivering into the airflow the vaporized content.
 6. The system of claim 1 for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the second phase program further comprises a programmable time-out process, which comprises: enabling, for an enablement time interval, the programmable vapor source to deliver into the airflow the nicotine-to-placebo ratio content, limiting, for a time-out time interval, the programmable vapor source into the airflow a placebo-only content, progressively increasing the time-out time interval, during at least a portion of the second phase change trajectory.
 7. The system of claim 1 for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the programmable vapor source comprises: a two-phase dynamic vapor delivery control logic, configured to generate vapor delivery commands in accordance with the first phase program and the second phase program; and a vapor content selection and delivery apparatus, supported by the portable structure and communicatively coupled to the vapor content control logic, comprising a first reservoir configured to hold an amount of nicotine-containing liquid, a second reservoir configured to hold an amount of nicotine-free liquid, a first atomizer, having a first atomization surface in or incident to the inner passage, a first transfer element, configured to switch in accordance with the vapor delivery command between a first element OFF state and a first element ON state, the ON state providing transfer of content of the first reservoir to the first atomizer, a second transfer element, configured to switch in accordance with the vapor delivery command between a second element OFF state and a second element ON state, the ON providing transfer of content of the second reservoir to the second atomizer.
 8. The system of claim 7 for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein: the inner passage includes an inner passage first segment that extends to a passage neck-down, and an inner passage second segment that extends from the passage neck-down toward the puff opening, the first atomizer is positioned within the inner passage first segment, the second atomizer is positioned within the inner passage second segment, the inner passage first segment has a passage first diameter, and an atomizer surface of the first atomizer extends across the passage first diameter, and the inner passage second segment has a passage second diameter, and an atomizer surface of the second atomizer extends across the passage second diameter.
 9. The system of claim 1 for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein: the mobile structure includes a case, the inner passage is within the case, and includes a mouthpiece structure, attached to or integral with the case, surrounds the puff opening, and the vapor content control logic comprises a distributed programmable vapor control processor, including a combination of an external programmable processing resource external to the case, a local vapor control resource supported within the case, and a local protocol communication link between the external programmable processing resource and the local vapor control resource.
 10. A method for two-phase dosage control (TPDC) based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, comprising: responsive to a first succession of instances of a subject's puff induced airflow through a passage toward a puff opening, delivering from the puff opening corresponding instances of a vaporized nicotine, at dosages in accordance with a first phase program, wherein the delivering includes receiving information indicative of puff characteristics of the subject that relate to actual received nicotine dosage by the subject relative to vaporized nicotine delivery operation by the system and, based on the information, performing adjustments of the delivery to conform the actual received dosage to the first phase program; responsive to second first succession of instances of the subject's puff induced airflow, delivering from the puff opening corresponding instances of a vaporized nicotine-to-placebo ratio content and changing the ratio, according to a second phase content change trajectory, from a starting, non-zero nicotine-to-placebo ratio to an effective zero nicotine-to-placebo ratio.
 11. The method of claim 10 for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the method further comprises: counting first phase puffs by the subject, and counting first phase puff sessions by the subject, each of the first phase puff sessions comprising a respective plurality of separate first phase puff actions by the subject, and counting second phase puffs by the subject, and counting second phase puff sessions by the subject, each of the second phase puff sessions comprising a respective plurality of separate second phase puff actions by the subject.
 12. The method of claim 11 for TPDC based electronic nicotine delivery treatment for of cessation of smoking and nicotine intake, wherein: changing, according to the second phase content change trajectory, from the starting, non-zero nicotine-to-placebo ratio to the effective zero nicotine-to-placebo ratio dosage includes effectuating at least of the ratio changes as a per-session ratio change, nicotine dosage change; and the second phase program is further configured to effectuate at least one of the ratio changes as a per-session ratio change.
 13. The method of claim 10 for TPDC based electronic nicotine delivery treatment for of cessation of smoking and nicotine intake, wherein the second phase dosage change trajectory is configured as statistically likely to result in an elimination of nicotine intake.
 14. The method of claim 10 for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the second phase program is configured to change the nicotine-to-placebo ratio by controlling a nicotine-to-placebo statistical ratio of a random selecting, on a per-puff basis, between nicotine content and placebo content, wherein: the random selecting includes generating a random number according to a uniform probability density function, and comparing the generated number against a selection comparison threshold, and changing the ratio comprises changing the stored selection comparison threshold to an updated selection comparison threshold.
 15. The method of claim 10 for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the first phase program further comprises a programmable lock-out process, which comprises: enabling, for an enablement time interval, the programmable vapor source to deliver into the airflow the vaporized content, and disabling, for a lock-out time interval, the programmable vapor source from delivering into the airflow the vaporized content.
 16. The method of claim 10 for TPDC based electronic nicotine delivery treatment for cessation of smoking and nicotine intake, wherein the second phase program further comprises a programmable time-out process, which comprises: enabling, for an enablement time interval, the programmable vapor source to deliver into the airflow the nicotine-to-placebo ratio content, limiting, for a time-out time interval, the programmable vapor source into the airflow a placebo-only content, progressively increasing the time-out time interval, during at least a portion of the second phase change trajectory. 